IGF1 Generation Test

Pfizer82 enrolled

Overview

To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Growth Hormone Deficiency

Interventions

Blood samplePROCEDURE

RadiographyPROCEDURE

Eligibility

Sex: ALLMin age: 4 YearsMax age: 11 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female aged of more than 4 years. * GHD defined as a peak GH level \< 20 mUI/ml at two different pharmacological GH provocative tests including one done with two pharmacological agents and both performed within the year before the inclusion, according to the current recommendations of the French Health Authorities Exclusion Criteria: * Previous treatment with GH * Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy

Locations (8)

Pfizer Investigational Site

BesanÃ§on, France

Pfizer Investigational Site

Bordeaux, France

Pfizer Investigational Site

Dunkirk, France

Pfizer Investigational Site

Limoges, France

Outcomes

Primary Outcomes

Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.

Data from ClinicalTrials.gov

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